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    Associate Director, Global Pharmacovigilance Quality Management

    Sarepta Therapeutics
    8-10 years
    $156,000 - $195,000 per year
    Remote, USA
    10 July 22, 2024
    Job Description
    Job Type: Full Time Education: B.Sc./ M.Sc./ M.Pharm/ B.Pharm/ Life Sciences Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, GCP guidelines, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

    Position: Senior Manager, Pharmacovigilance Quality Management
    Location: Remote (with occasional on-site presence at Sarepta facilities in the U.S. and attendance at Company-sponsored events)
    Salary Range: $156,000 - $195,000 per year

    About the Role:

    The Senior Manager, Pharmacovigilance (PV) Quality Management at Sarepta Therapeutics will lead global quality management activities for both investigational and marketed products. This role demands a collaborative leader with strong systems-thinking and quality management expertise. Reporting directly to the Director of Pharmacovigilance Quality Management, the incumbent will oversee the development and implementation of quality strategies and programs within the PV department.

    Primary Responsibilities:

    • Facilitate strategic planning and quality cycle processes for PV.
    • Map new and existing PV processes using MS Visio.
    • Develop and manage a comprehensive PV training program, including creating curricula and content for internal and external stakeholders, and act as a PV expert trainer.
    • Use industry-standard project management methods to manage projects effectively.
    • Implement and maintain a PV self-inspection program, ensuring inspection readiness.
    • Represent PV during audits and inspections, interacting directly with auditors and inspectors.
    • Monitor Key Performance Indicators (KPIs) and metrics, and coordinate data collation for management reports and scorecards.
    • Oversee compliance with PV plans, SOPs, regulations, and guidelines for both Sarepta and vendor PV activities.
    • Review and manage PV documented procedures, records, and agreements including Safety Data Exchange Agreements.
    • Manage CAPA and deviation processes internally and with PV vendors.
    • Collaborate with Clinical Development, Regulatory Affairs, Quality Assurance, Medical Affairs, Manufacturing, Legal, and other functional areas to enhance PV processes.
    • Identify, analyze, and implement continuous improvements for PV processes and systems.
    • Support the Director of Pharmacovigilance Quality Management in developing and executing PV processes and systems.

    Desired Education and Skills:

    • Advanced degree in Biological Sciences, Nursing, or Healthcare Administration.
    • 8-10 years of experience in PV Quality Management.
    • Strong skills in systems thinking, strategic planning, and quality management.
    • Excellent oral and written communication skills.
    • Proficiency in CAPA, project management, document management, and training.
    • Experience with MS Visio.
    • Ability to build relationships and influence across disciplines and levels.
    • Knowledge of global regulations for safety and pharmacovigilance, including FDA, EMA, and ICH guidelines.
    • Alignment with Sarepta’s core values: Patients First, Action, Unconventional Thinking, Talent, and Integrity.
    • Global experience is preferred.
    • Occasional travel may be required.

    Additional Information:

    This position is remote but will require occasional on-site presence at Sarepta’s U.S. facilities and participation in Company-sponsored events. The targeted salary range is based on Sarepta’s compensation philosophy and factors such as education, experience, and market conditions.

    Equal Opportunity Employer:

    Sarepta Therapeutics is an Equal Opportunity/Affirmative Action employer and participates in e-Verify. We are committed to creating a diverse and inclusive environment where all employees are valued and can thrive. Candidates must be authorized to work in the U.S.

    Sarepta Therapeutics offers a competitive compensation and benefits package.

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